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从打印设置到打印板性能:研究基于颗粒的直接挤出添加剂制造中的关键质量属性

Lotte De Wever¹, Caitlin Goemaere¹, Giorgio Peroni²

¹Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium.

International journal of pharmaceutics

|October 19, 2025

概括

基于颗粒的直接挤出添加剂制造 (DEAM) 与化丝制造 (FFF) 相比,为个性化药品提供了更大的灵活性. 这项研究证明了DEAM.

科学领域:

添加剂制造添加剂制造添加剂制造
制药科学制药科学
材料科学材料科学材料科学

背景情况:

针对个性化医疗的化纤维制造 (FFF) 受到材料限制的限制.
使用颗粒的直接挤出增材制造 (DEAM) 提供了一个潜在的替代方案.
这项研究调查了具有具有挑战性的神素配方的DEAM.

研究的目的:

为了评估基于颗粒的DEAM用于制药剂量形式.
通过设计实验优化颗粒的特性.
评估打印参数对3D打印平板电脑质量的影响.

主要方法:

颗粒是通过热挤出从易碎的theophylline/Soluplus®配方准备的.
双螺丝挤出参数 (螺丝速度,桶/模具温度) 针对颗粒质量进行了优化.
一个完整的因数设计评估了平板电脑属性的打印参数 (打印温度,充填,重叠,挤出乘数).

主要成果:

压温度显著影响了颗粒的脆性和视觉质量.
填充,挤出乘数和重叠影响了平板电脑质量和机械性能.
孔隙性和溶解与充填和挤出倍数有关;打印温度影响了溶解率.
在整个过程中观察到优异的内容统一性和没有API降解.

结论:

基于颗粒的DEAM克服了用于制药制造的FFF材料限制.
挤出倍数是量身定制剂量,多孔度和溶解的关键参数.
迪姆使多功能口服固体剂型具有增强的个性化功能.

关键词:

通过3D打印打印3D打印.关键的质量属性是关键的质量属性.设计实验的设计.直接挤出添加剂制造直接挤出添加剂制造颗粒颗粒是一种颗粒.个性化医疗是个性化的医疗.

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